In stage 2 of the study, the committee is selected and approved. Obviously, the composition of the committee is one of the most significant influences on the final outcome, and so great care must be taken at this stage. Committee members are screened for conflicts of interest, defined as:

"any financial or other interest which conflicts with the service of the individual because it could significantly impair the individual’s objectivity or could create an unfair competitive advantage for any person or organization. The term “conflict of interest” means something more than individual bias. There must be an interest, ordinarily financial, that could be directly affected by the work of the committee."

It is critically important that we understand this. A point of view or bias is not always a conflict of interest. This is good and bad for us. It’s good because it means that the experts who signed the letter to HHS should not be automatically disqualified for having done so. Their publicly expressed point of view should not, by itself, prevent their appointment to the committee. But it’s bad for us because it means that those who believe ME/CFS is a psychological disorder will also not be automatically disqualified.

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'A point of bias is not always a conflict of interest', Jennie states. She says that because of this fact, the 50 experts would not be eliminated.

I read this information differently. They state; any financial or other interest..could significantly impair the individual's objectivity...

How objective regarding other definitions could one be if they have just adopted the CCC over all the rest?

Futhermore,

At last month's FDA call with stakeholders, when asked about panel selection at the FDA this is what the transcript revealed:

Sandra Kweder: I think it's a good summary Terri, in order to, you know, one of the challenges
that we often has is and it's not unique to this condition, but just as a general
comment, we often have the challenge of some of the experts who we would
like to have sit on the panel, we can't have sit on the panel because they are
considered to have a conflict of interest.

So for example, we often find ourselves where we can't get an expert in a
particular disease because that expert, him or herself has been deeply involved
in clinical studies of the disease. And because of that, they are considered by
the rules governing advisory panels in general, to have a conflict of interest.
And so they are excluded from the conversation, it's very, very frustrating for
us and we work very hard to find good experts and sometimes where we know
of people we don't even go through the exercise of inviting them because we
already know what their conflicts are and that they would never pass.

And so it's a continuing challenge and we are often in a position of reaching
out to communities to ask for suggestions for additional experts.

Dr. Kweder is saying that they can't get experts in a particular disease to serve on their panel since that would constitute a 'bias'. She basically spell it out for us. e don't even have to read between the lines.

How many experts in GWI do they have on the panel to re-define that disease? This is how these panels work and that is exactly why the venue of the contract with IOM to define diseases makes no sense. It can never work, This is not what the IOM does.

What do you think rheumatoid arthritis patients would do if HHS would take the latest diagnostic criteria by the RA Foundation and say, no we will not adopt that one, we will give a contract to the IOM who in turn will select a panel of mostly non-experts in order to re-define RA.?

'A point of bias is not always a conflict of interest', Jennie states. She says that because of this fact, the 50 experts would not be eliminated.

I read this information differently. They state; any financial or other interest..could significantly impair the individual's objectivity...

How objective regarding other definitions could one be if they have just adopted the CCC over all the rest?

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The IOM website also states that a point of view or bias is not necessarily a conflict of interest. Here's the direct quote:

Point of View is different from Conflict of Interest.A point of view or bias is not necessarily a conflict of interest. Committee members are expected to have points of view, and the National Academies attempt to balance these points of view in a way deemed appropriate for the task. Committee members are asked to consider respectfully the viewpoints of other members, to reflect their own views rather than be a representative of any organization, and to base their scientific findings and conclusions on the evidence. Each committee member has the right to issue a dissenting opinion to the report if he or she disagrees with the consensus of the other members.

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If I am wrong on this point, then this is an argument for burying the experts' letter rather than continuing to promote it with HHS, etc. If that is the kind of bias that can get an expert disqualified, then it was a tremendous political mistake for the experts to sign that letter, and a compounded mistake to continue to promote the letter. The counter-argument is that if the experts have conflicted themselves out, then we have to force the cancellation of the contract. But if that effort fails, what then?

At last month's FDA call with stakeholders, when asked about panel selection at the FDA this is what the transcript revealed:. . . .

So for example, we often find ourselves where we can't get an expert in a
particular disease because that expert, him or herself has been deeply involved
in clinical studies of the disease. And because of that, they are considered by
the rules governing advisory panels in general, to have a conflict of interest.
. . .

Dr. Kweder is saying that they can't get experts in a particular disease to serve on their panel since that would constitute a 'bias'.

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The FDA conflict of interest rules for advisory committees are stringent. If a researcher has done research on drug A, and then drug B (a competitor's product) comes up for approval, the researcher working on drug A will be excluded from reviewing drug B. The relationship with a competitor of drug B is enough to create a conflict of interest. That may or may not be the way the IOM looks at conflicts.

Those are some good points about the letter and the experts on it. One issue I have thought about is that most of the experts apply for and use government grants. That creates an instant conflict of interest I suspect. Unless grants are excluded (and they might be, that comes under fine print) most of our experts are out. The FDA quote indicates this might be the case. Being involved in research studies is a huge problem, as most experts in ME are researchers. That will only leave clinicians ... but if they have published papers then does that count as research? How many of the leading ME clinicians have not published papers?

If I am wrong on this point, then this is an argument for burying the experts' letter rather than continuing to promote it with HHS, etc. If that is the kind of bias that can get an expert disqualified, then it was a tremendous political mistake for the experts to sign that letter, and a compounded mistake to continue to promote the letter. The counter-argument is that if the experts have conflicted themselves out, then we have to force the cancellation of the contract. But if that effort fails, what then?

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Unless they want to disqualify ME/CFS experts, and are actively looking for reasons/excuses to disqualify them, then the letter doesn't really say anything except that the experts have an opinion about their field. If being professionally involved in the field of ME/CFS, and having an opinion about diagnostic criteria, means that the experts will be disqualified, then that would disqualify almost everyone involved in the field. (All experts have opinions.) So I hope the letter won't make a difference, but who knows.

Let's say Snell is an expert advanced to the committee for the purposes - primarily - of promoting his/his team's repeat exercise testing.

I would advance then the argument would be he/his team had a conflict. The panel would want/need to review the evidence independently i.e. they should not be directly associated with this research.

His/his team's research can/should be advanced to the panel as 'research in progress' or 'interesting and supportive research in need of replication' etc. but for Snell to be there as an expert promoting his own research would be seen as a conflict.

That's my example - bearing in mind it's 03.40 in the morning and I've had another crap night - but I think this might be a comparison to Jennie's example of drug researchers (above).

What do you think?

N.B. General Note: We have been having some problems with my username. Russell had already been taken, so we went with Russell. but this proved hard for people to 'tag', and Russ was taken as well. So I'm back to Firestormm

Gabby, I think the only clinical trial conflicts we would have would be Rituxin and Ampligen, which would disqualify a number of experts. Like Jennie, I don't know how much of a conflict participating in a clinical trial would be considered by IoM.

I don't think they would consider signing the Expert Letter a conflict of Interest

But we do have the general problem that they openly state that they try to minimize the number of people who are researching the disease, because they could be swayed by having to apply to NIH for future grants and also IoM wants a broader perspective than can be provided by people in the field. Pretty stupid actually.

"deeply involved in clinical trials" doesn't really sound like most of our experts. It might exclude someone who has extensively studied antivirals, for instance, perhaps especially if they liked one particular antiviral or seemed to have ties to a pharmaceutical company,

but it shouldn't exclude anyone who is doing research of biomarkers and pathology, and has not done many treatment trials and is not currently closely involved with clinical trials.

on the good side, it might exclude many of the Axis of Evil, as they do lots of clinical trials. As this is for non-pharmaceutical things there could be an exception, but it's still an intellectual conflict of interest (plus they would lose face and their life's work, when people realize they are wrong) and it's financial, too, because they are providing the service they are promoting.

I think it should be possible for us to argue that the cognitive-behavioural postition is defunct, and the "broad perspective" should include differing theories about infections and immunity (it's solely/mainly enterovirus, it's a lot of CMV, EBV, and HHV-6, it's actually not the type of infection that matters but what the body does about it, active versus past infections, it's actually an autoimmune disease, etc.)

The HHS said these decisions are best turned over to people who are not biased. Which implies that they think the experts are biased, and their consensus cannot be trusted. Otherwise they would have put them in the drivers seat, instead of having the IOM run the show. Of course being a non-expert doesn't make one unbiased, so it's all so much smoke anyway.

The HHS said these decisions are best turned over to people who are not biased. Which implies that they think the experts are biased, and their consensus cannot be trusted. Otherwise they would have put them in the drivers seat, instead of having the IOM run the show. Of course being a non-expert doesn't make one unbiased, so it's all so much smoke anyway.

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It also implies that a govt. agency might be considered biased, e.g. CDC, hence why perhaps the IOM were afforded the contract given it's independence. I think this was what Jennie was referring to above - and I tried to in my previous post (although I am still confused with 'bias' and 'conflict of interest').

IOM are not I don't think inviting experts or anyone else for that matter as either 'witnesses' or panel members. They seem to be replying on nominations or volunteers - though I don't know (haven't really had time to read the details) how they will actually make their choices: but then how does any committee? I suppose they have only so many places at the table - sorry Jennie you probably explained all this and I am forgetting!

'Advocates' have been nominating, presumably members for the panel. And I guess others have been volunteering themselves for the panel. A panel that will aim to review the evidence placed before them, using their respective expertise and insight, to arrive at whatever it is they are meant to be arriving at. Perhaps the panel will invite 'expert witnesses' in regard to specific points, and as Jennie does point out, there will be opportunities for 'advocates' and patients to give testimony.

I still think I need more details - as I'm not clear in my head what exactly they hope to be recommending, the specific of the recommendation I mean: and what they will be taking into consideration.

They are just words that mean nothing. It is the actions that counts! Patient nominate, IOM appoints!

IOM willl not overrule 20 years of CDC/GET by the CDC/NIH or CAA. They will not over turn VA IOM Ruling of CFS!!!

GET THIS THROUGH YOU BRAIN FOG!!! IT'S NOT GOING TO HAPPEN. THE 35 YEAR HISTORICAL RECORD SUPPORTS THIS POSITION AND DOES NOT SUPPORT YOUR HOPES.

There is no direct proof of medical causation for ME/CFS,NICE will bring in PACE so that CFS wiil be determined to be a psychogenic disorder by the APA, Insurance lobbyists & HSS limiting psychiatric treatments at patients expense.

This is what CAA wants. This is what APA wants. This is what HHS wants. This is what CDC. MAYO, NIH wants. This is what the medical, health,and disability insurance want. They have no significant oppositions to this plan.

Any attorney worth his or her salt should know administrative law! Any attorney who knows anything about legal trial advocacy and is working on behalf of the patient community does not buttress the opposing witness's credibility!!

A good attorney instead attacks the opposing witness that HHS appointed to the panel by attacking the witness's weaknesses and their lack of credibility through research which implicate a conflict of interest by mixing cohorts with pyschiatric disorders as Reeves and Vernon did doing their research of the ME/CFS under Fukuda, Holmes or Reeves criteria. Too much money invested in CBT/GET by Welcome Trust and others to dismiss it.

Bottom Line. CFS will be interpreted in the same way as the VA IOM Panel, Otherwise HHS wouldn't have sifted so fast in this direction. You will lose on this one!!!

Finally, this is what the patient community wants by their apathy and lack of concern and lack of participation and by supporting those organizations that have sold them out!!

You are letting 50 researchers/clinicians and 66 some advocates to hang out to dry by hoping that the CAA and Pandora and HHS will come through for YOU this time and be nice to this community after a 35 year history of abuse. Words mean nothing, Focus on their Actions!!

You have two organizations that take in a lot of donations from patients that pay six figure incomes for two people to crank out one newsletter and a blog once a month and attend some conferences and is rated 2 stars by charity rating organization on fiances. Would you like to make $$$,$$$ figure income for writing a blog on PR and sending out a newletter each month. Most companies have salary tied into paid for performance. If they do not meet their performace objectives, their salary is reduced. $500K could go to a lot of research if they really cared about their patients. It's a good racket to get into and pretend you are serving the patient community when in fact you have ties to HSS.

You been sold down the river on this one by not rising to the occasion of 850,000K strong ME/CFS patients. Instead, we have about 35 active people working to make a difference.....sad really.

So don't complain when this goes against you and it will! You will get what you deserve by your inaction!

Of course being a non-expert doesn't make one unbiased, so it's all so much smoke anyway.

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non-experts are very likely to be biased for the simple reason that they have been being given biased information, and they have no knowledge to counter it with. It's possible to un-bias a non-expert by explaining things or if they themselves really look at the research, but this first requires that the non-expert be motivated, and motivated people are very hard to come by.

non-experts are very likely to be biased for the simple reason that they have been being given biased information, and they have no knowledge to counter it with. It's possible to un-bias a non-expert by explaining things or if they themselves really look at the research, but this first requires that the non-expert be motivated, and motivated people are very hard to come by.

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Not just motivation. The amount of work involved in this will likely preclude proper examination at other than a superficial level. At that level the issues cannot be really seen. There will be no time allowed to properly figure things out.

The IOM website also states that a point of view or bias is not necessarily a conflict of interest. Here's the direct quote:

If I am wrong on this point, then this is an argument for burying the experts' letter rather than continuing to promote it with HHS, etc. If that is the kind of bias that can get an expert disqualified, then it was a tremendous political mistake for the experts to sign that letter, and a compounded mistake to continue to promote the letter. The counter-argument is that if the experts have conflicted themselves out, then we have to force the cancellation of the contract. But if that effort fails, what then?

The FDA conflict of interest rules for advisory committees are stringent. If a researcher has done research on drug A, and then drug B (a competitor's product) comes up for approval, the researcher working on drug A will be excluded from reviewing drug B. The relationship with a competitor of drug B is enough to create a conflict of interest. That may or may not be the way the IOM looks at conflicts.

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(my bold)

I am sure that the 50 experts have considered what the political ramifications of their strong unwavering position would mean. They had time to think about it between the first and second letter, giving them a chance to remove their names if they so wished. In their letter, they state:

In addition, we strongly urge you to abandon efforts to reach out to groups such as the Institute
of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for
ME/CFS. Since the expert ME/CFS scientific and medical community has developed and
adopted a case definition for research and clinical purposes, this effort is unnecessary and
would waste scarce taxpayer funds that would be much better directed toward funding research
on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging
non-experts in the development of a case definition for a complex disease about which they are
not knowledgeable. (my bold)

The experts know exactly what the IOM is and how they function. They know that if this is not stopped it will fail. This is why 50 of them and many advocates are fighting so hard to stop this.

Unless we have a total majority of experts on the panel who understand the disease, it will produce a diagnostic criteria much broader than the CCC.

Your concern, @jspotila, is what if we fight and we fail to stop it? At least, we would have fought and it will show in the records that this was conceived against all stakeholders! The outcome, in my personal opinion will be the same. This is just a smokescreen that we feel we have the 'privilege' to nominate for the panel. The IOM will do the selecting. They will not select a panel where the outcome will be a definition of CCC or close to it. Their 'sponsor' would not be too satisfied to have spent a million dollars to come up with a set of criteria that we already have.

But we do have the general problem that they openly state that they try to minimize the number of people who are researching the disease, because they could be swayed by having to apply to NIH for future grants and also IoM wants a broader perspective than can be provided by people in the field. Pretty stupid actually.

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Where did IOM say they try to minimize the number of people who are researching the disease?

. . . I think this was what Jennie was referring to above - and I tried to in my previous post (although I am still confused with 'bias' and 'conflict of interest').

. . . .

I still think I need more details - as I'm not clear in my head what exactly they hope to be recommending, the specific of the recommendation I mean: and what they will be taking into consideration.

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I'm going to reach out to the communications person at IOM to see if we can get more info on bias v. conflict of interest. But here is what I know:

IOM is inviting people to join the committee. They solicited nominations from ME/CFS organizations, ME/CFS advocates, and I'm assuming from other sources. Those other sources could include their own membership, prominent scientists, agencies . . . I have no idea. Just guessing. However, I know of one ME/CFS expert who has received an invitation letter. I assume there will be more than one.

Committee members are invited to serve based on their expertise and knowledge base. If you recall, the nomination solicitation (and the Statement of Work) listed a number of areas of expertise. I think it is reasonable to assume that not all the members will be ME/CFS experts, and of course our worst case scenario is that there are only one or two. IOM is well aware of how we will perceive a committee with only one or two experts. I told them, and I know others have as well.

Committee members are NOT chosen to represent an organization, a group, or their own research interests. They are asked to use their expertise and knowledge base to evaluate the evidence and draw their own conclusions. This is how I was trained for FDA as well: you must evaluate all the evidence fairly, apply your expertise, listen to the other committee members and arrive at your own conclusions.

From what I can tell, the committee can invite specific people to speak at the public meetings. I think one of the GWI case definition public meetings earlier this year included panels, and I assumed those panelists were invited to speak. I think they also accept general comment, but that is determined by each committee.

The provisional committee list will come out the end of November or early December. We will have only twenty days to respond. I think it is vitally important that we do, and that we raise any and all concerns we have about committee members' biases, conflicts of interest, connections to insurance companies, etc. I've started compiling the names that organizations have been willing to share with me (which is by no means all of them), and my intention is to turn around background information very quickly when the slate comes out. It means doing in depth research into backgrounds in a 24 hour window and then writing up summaries to share with the community. I could use help, so if you are able to do detailed research and writing in such a short window (that we don't know when it will occur!) please email me at jspotila@yahoo.com.